The leading enterprise of molecular diagnosis Sansure Biotech Inc(688289) has received great news.
On May 22, Sansure Biotech Inc(688289) announced that the company’s three products – hepatitis B virus nucleic acid detection kit (PCR fluorescence method), hepatitis C virus nucleic acid detection kit (PCR fluorescence method) and human immunodeficiency virus type 1 nucleic acid detection kit (PCR fluorescence probe method) have recently obtained EU CE certification (IVDD list class a).
The announcement shows that among the categories of EU CE certification, list a products are subject to the highest degree of regulation and strict technical requirements. The verification, evaluation and audit intensity required is high and the certification is difficult. Obtaining this certification fully reflects the R & D and innovation strength, product quality and reliable performance of the enterprise.
Sansure Biotech Inc(688289) said that at present, only a handful of enterprises have passed CE list a certification. After several international brands such as Abbott and Roche have been certified, Sansure Biotech Inc(688289) has obtained CE list a product certification, which is also the first time that three nucleic acid detection reagents for blood borne infection in Chinese enterprises have been approved CE list a certification.
. Through the high-precision and automatic detection scheme, the above products can accurately and efficiently detect the virus content, assist in the monitoring of clinical treatment effect, and help prevent and control major infectious diseases such as hepatitis and AIDS around the world.
Sansure Biotech Inc(688289) also said that the above products of the company can be sold in EU countries and countries that recognize EU CE certification after obtaining EU CE list class a certification. The above products can meet the clinical needs. Therefore, the company’s overseas sales product category has been further expanded, which plays a positive role in the company’s sales and international business development.
In addition, on May 22, the official official account of Sansure Biotech Inc(688289) said that the company had reserved monkeypox virus nucleic acid detection kit (PCR fluorescent probe method) in its scientific research products, and monkeypox virus could be quickly identified by specifically detecting the nucleic acid fragments of monkeypox virus. The reagent has the characteristics of high sensitivity and simple operation. It is suitable for rapid diagnosis of related diseases caused by monkeypox virus infection. It is compatible with fluorescent PCR platform and Sansure Biotech Inc(688289) poct platform. It can be quickly applied to the established covid-19 nucleic acid detection platform.
Sansure Biotech Inc(688289) said that the company’s covid-19 related products have served more than 160 countries and regions around the world and helped the nucleic acid detection capacity of tens of thousands of laboratories outside China grow from nothing or several times to tens of times. Based on the strong covid-19 nucleic acid detection capacity, it can help laboratories in various countries carry out monkeypox virus nucleic acid detection efficiently and help the rapid diagnosis, prevention and control of monkeypox. At present, the company is actively promoting the overseas registration of the product.
